Dipl.-Phys.

König, Niels

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  • Publication
    Needle to needle robot‐assisted manufacture of cell therapy products
    ( 2022)
    Ochs, Jelena
    ;
    Hanga, Mariana P.
    ;
    Shaw, Georgina
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    Duffy, Niamh
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    Kulik, Michael
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    Tissin, Nokilaj
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    Reibert, Daniel
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    Biermann, Ferdinand
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    Moutsatsou, Panagiota
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    Ratnayake, Shibani
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    Nienow, Alvin
    ;
    König, Niels orcid-logo
    ;
    Schmitt, Robert
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    Rafiq, Qasim
    ;
    Hewitt, Christopher J.
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    Barry, Frank
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    Murphy, J. Mary
    Advanced therapeutic medicinal products (ATMPs) have emerged as novel therapiesfor untreatable diseases, generating the need for large volumes of high-quality,clinically-compliant GMP cells to replace costly, high-risk and limited scale manualexpansion processes. We present the design of a fully automated, robot-assistedplatform incorporating the use of multiliter stirred tank bioreactors for scalable pro-duction of adherent human stem cells. The design addresses a needle-to-needleclosed process incorporating automated bone marrow collection, cell isolation,expansion, and collection into cryovials for patient delivery. AUTOSTEM, a modular,adaptable, fully closed system ensures no direct operator interaction with biologicalmaterial; all commands are performed through a graphic interface. Seeding of sourcematerial, process monitoring, feeding, sampling, harvesting and cryopreservation areautomated within the closed platform, comprising two clean room levels enablingboth open and closed processes. A bioprocess based on human MSCs expanded onmicrocarriers was used for proof of concept. Utilizing equivalent culture parameters,the AUTOSTEM robot-assisted platform successfully performed cell expansion at theliter scale, generating results comparable to manual production, while maintaining cellquality postprocessing.
  • Publication
    Automation in the context of stem cell production - where are we heading with Industry 4.0?
    ( 2016)
    Kulik, Michael
    ;
    Ochs, Jelena
    ;
    König, Niels orcid-logo
    ;
    Schmitt, Robert
    As the field of cell and gene therapy continues to progress, the need for cell products for therapeutic application is increasing. In order to meet the demands, novel challenges particularly within the manufacturing of these products need to be overcome. By translating and applying automation solutions from the production industries into cell culture applications, standardized processing procedures can be introduced in order to reduce the variability, which is a critical issue within the manufacturing workflow. Additionally, the Industry 4.0 philosophy offers a variety of concepts for the design of adaptive processes that address the specific challenges in stem cell production. Novel tools such as data tracking, data analysis and machine learning are enabling technologies that will help support the safe manufacturing of effective products for future cell and gene therapies.